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Basaglar Vs Lantus Dosing

Fda Approves New Insulin Glargine Basaglar – The First “biosimilar” Insulin In The Us

Fda Approves New Insulin Glargine Basaglar – The First “biosimilar” Insulin In The Us

Twitter Summary: 1st ever “biosimilar” insulin approved in US – potential to come cheaper than other insulins, with launch in December 2016 Lilly/BI recently announced the FDA approval of its long-awaited biosimilar insulin glargine, Basaglar, for type 1 and type 2 diabetes. Basaglar is biologically similar to Sanofi’s basal insulin Lantus (insulin glargine), including the same protein sequence and a similar glucose-lowering effect. While the FDA does not call it a “biosimilar” drug for regulatory reasons, it can essentially be thought of as an alternative form of Lantus. Pricing for Basaglar is unknown at this time (more on this below), and the drug will not be launching in the US until after December 15, 2016. Why are “biosimilar” insulin options exciting? Most notably, they could potentially be offered at lower costs than brand name insulins. Basaglar has already launched in several international countries (under the brand name Abasaglar) and is typically priced at a 15%-20% discount relative to Lantus in those markets. It’s not clear yet how the discounts for Basaglar will compare in the US, and how much less patients with insurance might pay. “Generic” versions of drugs in the US typically come at a 50-80% discount to the original product. But unlike most generic drugs, biosimilar insulins are much more expensive to manufacture, so it’s unlikely they’ll see that same level of discount in the US. Indeed, Novartis launched the first “biosimilar” drug approved in the US last September (not in diabetes), which came at a 15% discount. Still, we’ve heard great optimism that biosimilar insulin glargine will help patients facing higher insulin costs. At the IDF conference in December, Dr. Matthew Riddle suggested that of all the insulins new Continue reading >>

Key Facts About Basaglar: A Less Expensive Long-acting Insulin

Key Facts About Basaglar: A Less Expensive Long-acting Insulin

If you’ve been using a long-acting insulin like Lantus, you might have heard about a friendly competitor called Basaglar which is coming soon to pharmacies. Basaglar is insulin glargine known as a biosimilar (also called a follow-on biologic). Because of the manufacturing process it isn’t considered a generic, but there are no differences from Lantus in regard to safety, purity and potency. To get to know Basaglar better, here are some details you’ll want to be aware of. What is the difference between a biosimilar and a generic? Generic drugs are copies of a brand name drug, and their manufacturing process can be replicated exactly through chemical reactions. Biologics are made using manufacturing processes and living organisms that are unique to each manufacturer. Therefore, it is not really possible to make an exact copy of a biologic. For an in-depth look at the definition of biosimilar, see here. Is Basaglar less expensive than Lantus? The cost of Basaglar is estimated to be about 20% cheaper than Lantus. It is manufactured by Eli Lilly as a KwikPen. Basaglar won’t be sold in a vial form. Will my insurance switch me to Basaglar? In some cases, yes. CVS Health has announced that Basaglar will be on formulary in place of Lantus. Is it really equivalent to Lantus? Yes, the onset, peak and duration of action are almost identical. Will my dose be the same as the insulin I’m currently taking? Your healthcare provider will tell you exactly how to make the switch. In general, Lantus and Basaglar can be interchanged unit for unit. If you were on Levemir, the conversion will also be unit for unit. If you were taking Levemir twice a day, the total number of units will likely be given as one Basaglar injection. If you are switching from Toujeo or NPH, your dose might Continue reading >>

Basaglar Dosage Guide - Drugs.com

Basaglar Dosage Guide - Drugs.com

Always check insulin labels before administration [see Warnings and Precautions ( 5.4 )]. Train patients on proper use and injection technique before initiating BASAGLAR. Visually inspect BASAGLAR KwikPen for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles. Inject between 1 and 80 units per injection. Administer BASAGLAR subcutaneously into the abdominal area, thigh, or deltoid, and rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy [see Adverse Reactions ( 6.1 )]. Do not dilute or mix BASAGLAR with any other insulin or solution as the onset of action or time to peak effect of BASAGLAR and the mixed insulin may be altered in an unpredictable manner. Do not administer intravenously or via an insulin pump because this could result in severe hypoglycemia. In patients with type 1 diabetes, BASAGLAR must be used concomitantly with short-acting insulin. Inject BASAGLAR subcutaneously once daily at any time of day but at the same time every day. Individualize and titrate the dosage of BASAGLAR based on the individual's metabolic needs, blood glucose monitoring results and glycemic control goal. Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), during acute illness, or changes in renal or hepatic function and should be made under medical supervision with appropriate glucose monitoring [see Warnings and Precautions ( 5.2 )]. The recommended starting dose of BASAGLAR in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short- or rapid-acting, pre-meal insulin should be used to sat Continue reading >>

Insulin Glargine

Insulin Glargine

Insulin glargine, marketed under the names Lantus, among others, is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. It consists of microcrystals that slowly release insulin, giving a long duration of action of 18 to 26 hours, with a "peakless" profile (according to the insulin glargine package insert). Pharmacokinetically, it resembles basal insulin secretion of non-diabetic pancreatic beta cells. Sometimes, in type 2 diabetes and in combination with a short acting sulfonylurea (drugs which stimulate the pancreas to make more insulin), it can offer moderate control of serum glucose levels. In the absence of endogenous insulin—type 1 diabetes, depleted type 2 (in some cases) or latent autoimmune diabetes of adults in late stage—insulin glargine needs the support of fast acting insulin taken with food to reduce the effect of prandially derived glucose. Medical uses[edit] The long-acting insulin class, which includes insulin glargine, do not appear much better than neutral protamine Hagedorn (NPH) insulin but have a significantly greater cost making them, as of 2010, not cost effective.[1] It is unclear if there is a difference in hypoglycemia and not enough data to determine any differences with respect to long term outcomes.[2] Mixing with other insulins[edit] Unlike some other longer-acting insulins, glargine must not be diluted or mixed with other insulin or solution in the same syringe.[3] However, this restriction has been questioned.[4] Adverse effects[edit] Cancer[edit] As of 2012 tentative evidence shows no association between insulin glargine and cancer.[5] Previous studies had raised concerns.[6] Pharmacology[edit] Mechanism of action[edit] Insulin glargine has a substitution of glycine for Continue reading >>

Lantus, Toujeo (insulin Glargine) Dosing, Indications, Interactions, Adverse Effects, And More

Lantus, Toujeo (insulin Glargine) Dosing, Indications, Interactions, Adverse Effects, And More

100 units/mL (Lantus SoloSTAR; Basaglar KwikPen; 3 mL disposable prefilled pens) 300 units/mL (Toujeo; 1.5 mL SoloStar disposable prefilled pen) 300 units/mL (Toujeo Max; 3 mL SoloStar disposable prefilled pen) Note: Recent studies have suggested that glargine-300 extends blood glucose control well beyond 24 hr Long-acting basal insulin indicated to improve glycemic control in adults with type 1 diabetes mellitus Start ~1/3 of total daily insulin dose; use remaining 2/3 of daily insulin dose on short-acting, premeal insulin Usual initial dose range: 0.2-0.4 units/kg; optimal glucose lowering effect may take 5 days to fully manifest and the first insulin glargine dose may be insufficient to cover metabolic needs in the first 24 hr of use Titrate insulin glargine per instructions, and adjust coadministered glucose-lowering therapies per standard of care See Dosing Considerations and Administration Long-acting basal insulin indicated to improve glycemic control in adults with type 2 diabetes mellitus Start 0.2 units/kg qDay; if necessary, adjust dosage of other antidiabetic drugs when starting insulin glargine to minimize the risk of hypoglycemia See Dosing Considerations and Administration Dose must be individualized based on clinical response; blood glucose monitoring is essential in all patients receiving insulin therapy Patients adjusting the amount or timing of dosage should do so only under medical supervision with appropriate glucose monitoring Titrate Toujeo dose no more frequently than every 3-4 days Use with caution in patients with visual impairment who may rely on audible clicks to dial their dose If changing from a treatment regimen with an intermediate- or long-acting insulin to a regimen with insulin glargine, the amount and timing of shorter-acting insulin Continue reading >>

Basaglar (insulin Glargine) Dose, Indications, Adverse Effects, Interactions... From Pdr.net

Basaglar (insulin Glargine) Dose, Indications, Adverse Effects, Interactions... From Pdr.net

Hormone secreted by pancreatic beta-cells of the islets of Langerhans and essential for the metabolism and homeostasis of carbohydrate, fat, and protein. Insulin glargine is a once-daily basal insulin analog without pronounced peaks. BASAGLAR, Lantus, Lantus SoloStar, Toujeo SoloStar BASAGLAR/Lantus/Lantus SoloStar/Toujeo SoloStar Subcutaneous Inj Sol: 1mL, 100U, 300U For the treatment of type 1 diabetes mellitus and type 2 diabetes mellitus. For the treatment of type 1 diabetes mellitus. Subcutaneous dosage (100 units/mL, i.e., Lantus, Basaglar) Initially, administer one-third of the total daily insulin requirements/dose subcutaneously once daily. Titrate dosage to achieve blood glucose control and A1C goals in conjunction with a short-acting insulin. Give the dose at the same time every day, at any time. Administration in the morning may avoid nocturnal hypoglycemia. When transferring from once daily NPH insulin, the dose is usually not changed. However, when transferring from twice-daily NPH insulin to insulin glargine, the total daily dose of NPH insulin (or other twice daily basal insulin) should be reduced by 20% and administered as single dose once daily. When transferring from once-daily Toujeo to once-daily Lantus or Basaglar, the recommended initial Lantus or Basaglar dose is 80% of the Toujeo dose that is being discontinued. Thereafter, the dosage of insulin glargine should be adjusted to response. Children and Adolescents 6 years and older Insulin requirements are highly variable and must be individualized based on patient-specific factors and type of insulin regimen. During partial remission phase, total combined daily insulin requirement is often less than 0.5 units/kg/day. Prepubertal children (outside the partial remission phase) usually require 0.7 to Continue reading >>

Basaglar® (insulin Glargine Injection) 100 Units/ml, For Subcutaneous Use – Eli Lilly And Company

Basaglar® (insulin Glargine Injection) 100 Units/ml, For Subcutaneous Use – Eli Lilly And Company

Cory Nelson, Pharm.D., North Memorial Camden Clinic Indication and Classification: Basaglar® (insulin glargine injection) is a long-acting, 100 unit/mL human insulin analog. As the first insulin product approved as a “follow-on product” by the FDA, Basaglar was able to prove itself similar enough to Sanofi-Aventis’s Lantus®, and use efficacy and safety evidence for Lantus® to support its approval. While the product is classified a biosimilar in other countries, United States (U.S.) law and Food and Drug Administration (FDA) regulation placed the product’s approval in a separate process from biosimilar approval. Basaglar® has received approval for all indications listed for Lantus®. Mechanism of Action: Basaglar®, like any insulin, primarily works by increasing peripheral glucose uptake and by inhibiting hepatic glucose production. A euglycemic clamp study involving 91 healthy adults given a 0.5 unit/kg bolus subcutaneously indicated sustained glucose lowering effect over 24 hours with no pronounced peak and a maximum effect at a median time of 12 hours after injection. Pharmacokinetic profile as determined by serum insulin concentrations during this study confirmed these results. This gives Basaglar® a similar pharmacokinetic/pharmacodynamic profile to Lantus®. Dosage and Administration: Basaglar® will be supplied only in a 5-pen box of 3 ml prefilled KwikPens. Pens should be refrigerated and can be stored at room temperature for 28 days used or unused. Recommended starting doses are approximately one-third of the total daily insulin requirements for patients with type 1 diabetes and 0.2 units/kg or up to 10 units daily for patients with type 2 diabetes. It can be interchanged unit for unit with other forms of U-100 insulin glargine such as Lantus®. Ef Continue reading >>

Long-acting Basaglar And The New Era Of “biosimilar” Insulin

Long-acting Basaglar And The New Era Of “biosimilar” Insulin

By Payal Marathe and Lynn Kennedy What you need to know about the new insulin, its cost, dosing, and beyond! On December 15, Basaglar became the first “biosimilar” insulin available in the US. Produced by Lilly and BI, it is injectable insulin glargine modeled after Sanofi’s basal insulin Lantus, with the same core protein sequence. Importantly, Basaglar offers another insulin option for people with diabetes – one that comes at a lower cost and with very similar glucose-lowering effects compared to Lantus. It is available in a disposable, pre-filled pen (called the KwikPen) and is approved for people with type 1 and type 2 diabetes. Basaglar’s December 2016 launch date was highly-anticipated because it actually received FDA approval a full year before, but shipments to US pharmacies were delayed until a legal settlement was reached with Sanofi. [Editor’s Note: The FDA does not consider Basaglar a “biosimilar” drug for regulatory reasons; but it can essentially be thought of as an alternative form of Lantus.] Now that Basaglar has finally arrived, what does this mean for diabetes treatment? What are the major advantages? What does it cost? How should it be used? What does it mean to be “biosimilar,” and how might biosimilar insulin change care for people with type 1 and type 2 diabetes? Read on to find out! Lower Costs in A New Age of Biosimilar Insulin? So, what’s the point of having two similar insulin glargine products out there? One important reason is that a biosimilar medicine will usually be priced lower than the original product – the idea is similar to “generic” medications taken as pills, like statins. Compared to Lantus, Basaglar’s list price offers an approximately 15% discount. Some big names in insurance (like UnitedHealth) are Continue reading >>

Basaglar

Basaglar

The FDA has approved Basaglar (insulin glargine injection; Eli Lilly and Company), a long-acting human insulin analog, to improve glycemic control in adults and children with type 1 diabetes and in adults with type 2 diabetes. The approval carries the limitation that Basaglar should not be used for the treatment of diabetic ketoacidosis.1 Basaglar has an identical amino acid sequence as Lantus, another U-100 insulin glargine,2 and was approved through an abreviated approval process that partly relied on the FDAs previous finding of safety and effectiveness for Lantus. Basaglar was found sufficiently similar to Lantus, and data were provided specific to Basaglar to establish its safety and efficacy for its approved uses.3 Insulins primary activity is the regulation of glucose metabolism. Insulin and insulin analogs stimulate peripheral glucose uptake, especially by skeletal muscle and fat, and inhibit hepatic glucose production to lower blood glucose. A single subcutaneous 0.5-U/kg dose of Basaglar demonstrated a serum concentration with a slow and prolonged absorption and a relatively constant concentration/ time profile over 24 hours, with no pronounced peak. The average time to maximum serum insulin concentration was 12 hours after injection. Serum insulin concentrations declined to baseline by approximately 24 hours.1 The dose of Basaglar should be individualized based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use. It should be given subcutaneously once daily, at the same time each day. The injection sites should be rotated to reduce the risk of lipodystrophy. When treatment with Basaglar begins, blood glucose levels should be monitored closely for the initial weeks. Basaglar should not be diluted or mixed wi Continue reading >>

Basaglar Kwikpen Side Effects

Basaglar Kwikpen Side Effects

What Is Basaglar Kwikpen? Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin glargine is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours. Insulin glargine is used to improve blood sugar control in adults and children with diabetes mellitus. Insulin glargine is used to treat type 1 or type 2 diabetes in adults, and type 1 diabetes children who are at least 6 years old. Some brands of this medicine are for use only in adults. Carefully follow all instructions for the brand of insulin glargine you are using. Insulin glargine may also be used for purposes not listed in this medication guide. Never share an injection pen or syringe with another person, even if the needle has been changed. You should not use this medicine if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar). Insulin glargine is not approved for use by anyone younger than 6 years old, and should not be used to treat type 2 diabetes in a child of any age. To make sure insulin glargine is safe for you, tell your doctor if you have: liver or kidney disease; low levels of potassium in your blood (hypokalemia); or diabetic ketoacidosis (call your doctor for treatment). Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems. Follow your doctor's instructions about using insulin if you are pregnant or breast-feeding a baby. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Your dose needs may also be dif Continue reading >>

Common Side Effects Of Basaglar (basaglar Insulin Glargine Subcutaneous Injection) Drug Center - Rxlist

Common Side Effects Of Basaglar (basaglar Insulin Glargine Subcutaneous Injection) Drug Center - Rxlist

Medical Editor: John P. Cunha, DO, FACOEP Basaglar (insulin glargine injection) is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Common side effects of Basaglar include low blood sugar ( hypoglycemia ), allergic reactions, injection site reactions, body fat redistribution, itching, rash, swelling, weight gain , upper respiratory tract infection , runny or stuffy nose , back pain , cough, urinary tract infection , diarrhea, depression, or headache. The dose of Basaglar is individualized based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes , and prior insulin use. Basaglar may interact with antidiabetic agents, ACE inhibitors , angiotensin II receptor blocking agents, disopyramide, fibrates , fluoxetine , monoamine oxidase inhibitors, pentoxifylline , pramlintide , propoxyphene , salicylates, somatostatin analogs, sulfonamide antibiotics, atypical antipsychotics, corticosteroids, danazol, diuretics, estrogens , glucagon , isoniazid, niacin , oral contraceptives, phenothiazines, progestogens, protease inhibitors, somatropin , sympathomimetic agents, thyroid hormones , alcohol, beta-blockers, clonidine , lithium salts, guanethidine, and reserpine. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or become pregnant while taking Basaglar. Insulin needs may change during pregnancy. It is unknown if Basaglar passes into breast milk. Insulin needs may change while a woman is breastfeeding. Consult your doctor before breastfeeding. Our Basaglar (insulin glargine injection) Side Effects Drug Center provides a comprehensive view of available drug information on the pote Continue reading >>

New Insulin Basaglar In Pharmacies This Year

New Insulin Basaglar In Pharmacies This Year

Basaglar (insulin glargine) is the newest brand of long-acting insulin to hit the market. It shares its active ingredient (insulin glargine) with Lantus, but is not a generic equivalent and the two can’t be substituted for each other. Long-acting insulin like Basaglar (also sometimes referred to as basal insulin) are used to keep blood glucose levels stable throughout the day. There are now four long-acting insulins approved by the FDA: Lantus, Levemir (insulin detemir), Toujeo (insulin glargine recombinant), Tresiba (insulin degludec), and Basaglar. Is there anything unique about Basaglar? Yes. Basaglar has been available in Europe, Canada, Columbia, Japan, and Australia as a new insulin glargine biosimilar to Lantus. It’s now on its way to the US. Does that mean Basaglar can be substituted for Lantus at the pharmacy? No. In the US, Basaglar was approved as a new drug, which means it has to prescribed by your doctor—or approved as a new prescription if you switch from Lantus. Although both Basaglar and Lantus are both insulin glargine they cannot be automatically substituted for one another without your doctor’s approval. How is Basaglar used? Dosing with Basaglar is individualized and will be determined by your doctor—not everyone will use the same amount. Basaglar is injected once-daily at any time of the day (but should be used at the same time every day). How will Basaglar be available? Basaglar is a solution for injection (100 units/mL) in a box of five 3 mL prefilled KwikPens. What are the side effects of Basaglar? The most common side effects associated with Basaglar are low blood sugar, allergic reactions, injection site reactions, itching, rash, and retaining water. When was Basaglar approved? Basaglar was approved by the FDA on December 16, 2015. Wh Continue reading >>

Should My Insulin Dose Be Lower? Toujeo Vs Lantus

Should My Insulin Dose Be Lower? Toujeo Vs Lantus

Early in 2015 the FDA approved the first concentrated long-acting insulin known as Toujeo (insulin glargine), and it’s now available in pharmacies. While Toujeo is the first of its kind, the key word is “concentrated.” It actually contains the same active ingredient (insulin glargine) as Lantus—which is currently the #1 prescribed insulin in the US. To make things even more confusing: Toujeo comes in a 300 mg/mL dosage, while Lantus is 100 mg/mL. Knowing that Toujeo is concentrated, you might think that you can take a much smaller amount of Toujeo for a similar dose compared to Lantus. Believe it or not though, that isn’t the case. Lantus and Toujeo doses are converted 1:1. This means that if you are injecting 50 units of Lantus, you can essentially be switched over to Toujeo and instructed to inject the exact same amount, 50 units. In reality, some dose adjustments can be expected (according to clinical trial data), but it isn’t a matter of converting to a three times smaller dose. Surprisingly, patients who switch over to Toujeo are actually injecting higher doses compared to what they were using for Lantus. I see a lot of confusion around the different dosages, and a few common questions: Is it normal for my dose of Toujeo to be more than my Lantus dose? Yes. Although Toujeo has three times the concentration of insulin glargine, patients treated with Toujeo during clinical trials used more insulin than patients treated with Lantus in order to maintain the same level of blood sugar control. According to the manufacturer, Sanofi-Aventis, a higher dose can be expected with Toujeo and is completely normal. Why would Sanofi-Aventis make Toujeo if Lantus is the most-prescribed insulin? There is speculation that Sanofi-Aventis came up with Toujeo due to the upco Continue reading >>

‘generic’ Basaglar Is Cheaper Than Lantus But Does It Work?

‘generic’ Basaglar Is Cheaper Than Lantus But Does It Work?

Basaglar U-100 insulin glargine, which is a follow-on biologic insulin to Lantus is now available by prescription in the US. Basaglar, from Eli Lilly and Company and Boehringer Ingelheim Pharmaceuticals, Inc. is not technically a generic to Lantus but it does have an amino acid sequence identical to Lantus and has been FDA approved as a long-acting insulin for patients of all ages with type 1 diabetes and adults with type 2 diabetes. David Kendall, M.D. and the vice president of Global Medical Affairs for Lilly Diabetes said in Lilly’s press release, “Lilly and Boehringer Ingelheim are proud to bring another proven effective diabetes treatment choice to people who may need a long-acting insulin to help control their blood sugar,” and that “We know that starting insulin can be a challenging experience for some people with type 2 diabetes. As part of our continuing commitment to the diabetes community, we are expanding our educational resources.” Is it Cheaper? Business Insider reported that Basaglar “is 15% less than the list price of Lantus and Toujeo, two long-acting insulins made by Sanofi Aventis, 21% less than the list price of Levemir, and 28% less than Tresiba, two long-acting insulins made by Novo Nordisk.” An Eli Lilly spokesperson told Business Insider that before discounts or insurance coverage, the list price for a 5-pen pack of Basaglar is $316.85. You will be able to get Basaglar from retail and mail order pharmacies. Basaglar has also been chosen for the formularies of the top three pharmacy benefit managers and is expected to be covered by many commercial insurance plans. The pharmacy benefit manager CVS Health has dropped Lantus and replaced it with Basaglar for their next year’s formulary. In their announcement, CVS Health stated that th Continue reading >>

Lillymedical Authentication

Lillymedical Authentication

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